JPH09500866A - 多粒状物の脈動性投薬システム - Google Patents
多粒状物の脈動性投薬システムInfo
- Publication number
- JPH09500866A JPH09500866A JP6517408A JP51740894A JPH09500866A JP H09500866 A JPH09500866 A JP H09500866A JP 6517408 A JP6517408 A JP 6517408A JP 51740894 A JP51740894 A JP 51740894A JP H09500866 A JPH09500866 A JP H09500866A
- Authority
- JP
- Japan
- Prior art keywords
- pellets
- environment
- population
- dosage form
- core
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 230000000541 pulsatile effect Effects 0.000 title claims abstract description 13
- 239000008188 pellet Substances 0.000 claims abstract description 75
- 239000003814 drug Substances 0.000 claims abstract description 63
- 239000002552 dosage form Substances 0.000 claims abstract description 37
- 238000000576 coating method Methods 0.000 claims abstract description 33
- 239000011248 coating agent Substances 0.000 claims abstract description 31
- 229940079593 drug Drugs 0.000 claims abstract description 29
- 229940124597 therapeutic agent Drugs 0.000 claims abstract description 28
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 26
- 239000003795 chemical substances by application Substances 0.000 claims abstract description 20
- 239000002775 capsule Substances 0.000 claims abstract description 9
- 230000000694 effects Effects 0.000 claims abstract description 3
- 229920003176 water-insoluble polymer Polymers 0.000 claims abstract 3
- 238000009792 diffusion process Methods 0.000 claims abstract 2
- 239000000463 material Substances 0.000 claims description 18
- 230000002209 hydrophobic effect Effects 0.000 claims description 15
- 229920001577 copolymer Polymers 0.000 claims description 11
- 230000010349 pulsation Effects 0.000 claims description 11
- NIXOWILDQLNWCW-UHFFFAOYSA-N acrylic acid group Chemical group C(C=C)(=O)O NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 claims description 8
- 125000005397 methacrylic acid ester group Chemical group 0.000 claims description 8
- 235000014113 dietary fatty acids Nutrition 0.000 claims description 7
- 239000000194 fatty acid Substances 0.000 claims description 7
- 229930195729 fatty acid Natural products 0.000 claims description 7
- 125000001453 quaternary ammonium group Chemical group 0.000 claims description 7
- 238000000034 method Methods 0.000 claims description 6
- 230000035699 permeability Effects 0.000 claims description 6
- 239000006057 Non-nutritive feed additive Substances 0.000 claims description 5
- 150000004665 fatty acids Chemical class 0.000 claims description 5
- 239000007788 liquid Substances 0.000 claims description 5
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims description 5
- 239000004014 plasticizer Substances 0.000 claims description 5
- 239000000829 suppository Substances 0.000 claims description 5
- 239000003826 tablet Substances 0.000 claims description 5
- 239000002253 acid Substances 0.000 claims description 4
- 239000000203 mixture Substances 0.000 claims description 4
- 229920000642 polymer Polymers 0.000 claims description 4
- 150000003839 salts Chemical class 0.000 claims description 4
- 238000013270 controlled release Methods 0.000 claims description 3
- 239000001993 wax Substances 0.000 claims description 3
- -1 Acrylic ester Chemical class 0.000 claims description 2
- 239000004925 Acrylic resin Substances 0.000 claims description 2
- 229920000178 Acrylic resin Polymers 0.000 claims description 2
- 229920003086 cellulose ether Chemical class 0.000 claims description 2
- 150000002170 ethers Chemical class 0.000 claims description 2
- 239000007903 gelatin capsule Substances 0.000 claims description 2
- 230000001225 therapeutic effect Effects 0.000 claims description 2
- HSUGRBWQSSZJOP-RTWAWAEBSA-N diltiazem Chemical compound C1=CC(OC)=CC=C1[C@H]1[C@@H](OC(C)=O)C(=O)N(CCN(C)C)C2=CC=CC=C2S1 HSUGRBWQSSZJOP-RTWAWAEBSA-N 0.000 claims 4
- 229960004166 diltiazem Drugs 0.000 claims 4
- 239000002861 polymer material Substances 0.000 claims 3
- 125000005396 acrylic acid ester group Chemical group 0.000 claims 2
- 230000001568 sexual effect Effects 0.000 claims 2
- 229940126585 therapeutic drug Drugs 0.000 claims 2
- VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical group CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 claims 1
- SMZOUWXMTYCWNB-UHFFFAOYSA-N 2-(2-methoxy-5-methylphenyl)ethanamine Chemical compound COC1=CC=C(C)C=C1CCN SMZOUWXMTYCWNB-UHFFFAOYSA-N 0.000 claims 1
- DCXXMTOCNZCJGO-UHFFFAOYSA-N Glycerol trioctadecanoate Natural products CCCCCCCCCCCCCCCCCC(=O)OCC(OC(=O)CCCCCCCCCCCCCCCCC)COC(=O)CCCCCCCCCCCCCCCCC DCXXMTOCNZCJGO-UHFFFAOYSA-N 0.000 claims 1
- CERQOIWHTDAKMF-UHFFFAOYSA-N Methacrylic acid Chemical compound CC(=C)C(O)=O CERQOIWHTDAKMF-UHFFFAOYSA-N 0.000 claims 1
- 230000015572 biosynthetic process Effects 0.000 claims 1
- 229920002678 cellulose Polymers 0.000 claims 1
- 239000001913 cellulose Substances 0.000 claims 1
- 150000002148 esters Chemical class 0.000 claims 1
- 125000005313 fatty acid group Chemical group 0.000 claims 1
- 229920003145 methacrylic acid copolymer Polymers 0.000 claims 1
- 125000005395 methacrylic acid group Chemical group 0.000 claims 1
- 239000003607 modifier Substances 0.000 claims 1
- 239000007889 pulsatile dosage form Substances 0.000 claims 1
- 239000002357 osmotic agent Substances 0.000 abstract description 7
- 239000007888 film coating Substances 0.000 abstract description 3
- 238000009501 film coating Methods 0.000 abstract description 3
- 239000008187 granular material Substances 0.000 abstract description 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 14
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 8
- 235000019359 magnesium stearate Nutrition 0.000 description 7
- 239000008280 blood Substances 0.000 description 6
- 210000004369 blood Anatomy 0.000 description 6
- 239000011230 binding agent Substances 0.000 description 5
- 230000036765 blood level Effects 0.000 description 4
- 230000003111 delayed effect Effects 0.000 description 4
- 239000011780 sodium chloride Substances 0.000 description 4
- 239000000725 suspension Substances 0.000 description 4
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 description 3
- 210000001035 gastrointestinal tract Anatomy 0.000 description 3
- 239000002609 medium Substances 0.000 description 3
- 239000008177 pharmaceutical agent Substances 0.000 description 3
- FEDJGPQLLNQAIY-UHFFFAOYSA-N 2-[(6-oxo-1h-pyridazin-3-yl)oxy]acetic acid Chemical compound OC(=O)COC=1C=CC(=O)NN=1 FEDJGPQLLNQAIY-UHFFFAOYSA-N 0.000 description 2
- 229920003161 Eudragit® RS 30 D Polymers 0.000 description 2
- 229920002472 Starch Polymers 0.000 description 2
- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 description 2
- 239000002131 composite material Substances 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 229960005316 diltiazem hydrochloride Drugs 0.000 description 2
- 239000006185 dispersion Substances 0.000 description 2
- 239000006260 foam Substances 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 210000002216 heart Anatomy 0.000 description 2
- 210000003734 kidney Anatomy 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 230000003204 osmotic effect Effects 0.000 description 2
- 239000000825 pharmaceutical preparation Substances 0.000 description 2
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 2
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 2
- 239000008107 starch Substances 0.000 description 2
- 235000019698 starch Nutrition 0.000 description 2
- URAYPUMNDPQOKB-UHFFFAOYSA-N triacetin Chemical compound CC(=O)OCC(OC(C)=O)COC(C)=O URAYPUMNDPQOKB-UHFFFAOYSA-N 0.000 description 2
- 230000004584 weight gain Effects 0.000 description 2
- 235000019786 weight gain Nutrition 0.000 description 2
- 235000019739 Dicalciumphosphate Nutrition 0.000 description 1
- JIGUQPWFLRLWPJ-UHFFFAOYSA-N Ethyl acrylate Chemical compound CCOC(=O)C=C JIGUQPWFLRLWPJ-UHFFFAOYSA-N 0.000 description 1
- 229920003163 Eudragit® NE 30 D Polymers 0.000 description 1
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- VVQNEPGJFQJSBK-UHFFFAOYSA-N Methyl methacrylate Chemical compound COC(=O)C(C)=C VVQNEPGJFQJSBK-UHFFFAOYSA-N 0.000 description 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 description 1
- 229930006000 Sucrose Natural products 0.000 description 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 description 1
- 230000002745 absorbent Effects 0.000 description 1
- 239000002250 absorbent Substances 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 239000003242 anti bacterial agent Substances 0.000 description 1
- 229940088710 antibiotic agent Drugs 0.000 description 1
- 239000002246 antineoplastic agent Substances 0.000 description 1
- 210000000436 anus Anatomy 0.000 description 1
- 239000012736 aqueous medium Substances 0.000 description 1
- 210000001124 body fluid Anatomy 0.000 description 1
- 239000010839 body fluid Substances 0.000 description 1
- 239000001506 calcium phosphate Substances 0.000 description 1
- 239000008116 calcium stearate Substances 0.000 description 1
- 235000013539 calcium stearate Nutrition 0.000 description 1
- 210000003169 central nervous system Anatomy 0.000 description 1
- 229940110456 cocoa butter Drugs 0.000 description 1
- 235000019868 cocoa butter Nutrition 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- NEFBYIFKOOEVPA-UHFFFAOYSA-K dicalcium phosphate Chemical compound [Ca+2].[Ca+2].[O-]P([O-])([O-])=O NEFBYIFKOOEVPA-UHFFFAOYSA-K 0.000 description 1
- 229940038472 dicalcium phosphate Drugs 0.000 description 1
- 229910000390 dicalcium phosphate Inorganic materials 0.000 description 1
- 239000007884 disintegrant Substances 0.000 description 1
- 238000010494 dissociation reaction Methods 0.000 description 1
- 230000005593 dissociations Effects 0.000 description 1
- 239000000890 drug combination Substances 0.000 description 1
- 229940126534 drug product Drugs 0.000 description 1
- 239000002662 enteric coated tablet Substances 0.000 description 1
- 230000007613 environmental effect Effects 0.000 description 1
- 239000000945 filler Substances 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 239000001087 glyceryl triacetate Substances 0.000 description 1
- 235000013773 glyceryl triacetate Nutrition 0.000 description 1
- 208000016354 hearing loss disease Diseases 0.000 description 1
- 239000012456 homogeneous solution Substances 0.000 description 1
- 239000005556 hormone Substances 0.000 description 1
- 229940088597 hormone Drugs 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 238000001802 infusion Methods 0.000 description 1
- 210000000936 intestine Anatomy 0.000 description 1
- 238000001990 intravenous administration Methods 0.000 description 1
- 239000008101 lactose Substances 0.000 description 1
- 229960001375 lactose Drugs 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 239000000314 lubricant Substances 0.000 description 1
- 238000002483 medication Methods 0.000 description 1
- 239000008108 microcrystalline cellulose Substances 0.000 description 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 description 1
- 229940016286 microcrystalline cellulose Drugs 0.000 description 1
- 210000003205 muscle Anatomy 0.000 description 1
- 230000007935 neutral effect Effects 0.000 description 1
- 230000035515 penetration Effects 0.000 description 1
- PNJWIWWMYCMZRO-UHFFFAOYSA-N pent‐4‐en‐2‐one Natural products CC(=O)CC=C PNJWIWWMYCMZRO-UHFFFAOYSA-N 0.000 description 1
- 239000008194 pharmaceutical composition Substances 0.000 description 1
- 229940127557 pharmaceutical product Drugs 0.000 description 1
- 229920006254 polymer film Polymers 0.000 description 1
- 230000035935 pregnancy Effects 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- KEAYESYHFKHZAL-OUBTZVSYSA-N sodium-24 Chemical compound [24Na] KEAYESYHFKHZAL-OUBTZVSYSA-N 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 239000007921 spray Substances 0.000 description 1
- 229940032147 starch Drugs 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 239000005720 sucrose Substances 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- 239000003204 tranquilizing agent Substances 0.000 description 1
- 230000002936 tranquilizing effect Effects 0.000 description 1
- 229960002622 triacetin Drugs 0.000 description 1
- 210000001215 vagina Anatomy 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
Description
Claims (1)
- 【特許請求の範囲】 1.a)使用の環境においてその一体性を維持しないキャリヤー・メジウムで あって、カプセル、錠剤、座薬およびパウチから成る群から選択されるものと、 b)前記キャリヤー・メジウムによって共に保持されるペレットの複数種 類の個体群であって、各個体群のペレットは、前記環境と接触した後、治療用薬 剤が異なった時間において前記環境内に放出されるように調整されているものと を含み、 c)各ペレットは1)前記治療用薬剤および治療用薬剤とは異なる薬剤で ある調節剤を含むコアであって、前記調節剤は水に可溶であり、溶解したとき浸 透圧効果を提供するものと、2)前記コアを包囲するコーチングであって、少な くとも1種類の水浸透性、フィルム形成、水不溶性ポリマー材料と疎水性剤とか ら成り、前記疎水性剤が脂肪酸、ワックスおよび脂肪酸の塩類から成る群から選 択され、前記水不溶性ポリマー材料の少なくとも25%の量をもって存在し、或 る個体群のペレットの全ては略均一なコーチングを備えており、これが前記環境 に暴露後、水を前記コアに侵入させ、かつこのコーチングを介して治療用薬剤を 特定の時間に前記環境内に拡散させ、そして d)各個体群のペレットは、それ以外の個体群のペレットとは異なった時 間において使用環境内に前記治療用薬剤を放出させるコーチングを備えており、 それによって前記個体群を全て同時に前記環境に暴露すると、複数の逐次的な治 療性放出状態を提供するが、各個体群は前記治療用薬剤について異なった時間の 放出を提供し、この場合各個体群のペレットは前記使用環境において平均放出時 間を有し、これは少なくとも1時間づつ他の全ての個体群のペレットの平均放出 時間とは別個であることを特徴とする水性液体含有環境内へ複数の逐次的、脈動 性放出状態において治療用薬剤を投与するための単位投薬フォーム。 2.各個体群のペレットが他の個体群のそれとコーチングの厚さにおいて異な っている請求項1記載の単位投薬フォーム。 3.前記フィルム形成、水不溶性ポリマー材料が、アクリルおよびメタクリル 酸エステルのコポリマー、アクリルおよびメタクリル酸エステルのコポリマーと 第4アンモニウム塩基、セルロース誘導体、およびアクリル樹脂から成る群の少 なくとも一種類から選択される請求項2記載の単位投薬フォーム。 4.前記治療用薬剤がdiltiazemの薬学的に受容可能な形態であり、前記コア は少なくとも一種類の加工助剤を含み、また前記フィルム形成ポリマー材料は、 少なくとも一種類の可塑剤との組合わせにおけるアクリルおよびメタクリル酸エ ステルと6%未満の第4アンモニウム基とのコポリマーを含んで成り、前記疎水 性剤は、前記ポリマー材料の少なくとも40%の量において存在するステアリン 酸塩である請求項2記載の投薬フォーム。 5.前記治療用薬剤がdiltiazemの薬学的に受容可能な形態であり、前記コア は少なくとも一種類の加工助剤を含み、また前記ポリマー材料はアクリルおよび メタクリル酸エステルのコポリマーを含んでおり、前記疎水性剤は、前記ポリマ ー材料の少なくとも40%の量において存在するステアリン酸塩である請求項2 記載の投薬フォーム。 6.少なくとも2種類の個体群のペレットが存在する請求項2記載の投薬フォ ーム。 7.少なくとも3種類の個体群のペレットが存在する請求項2記載の投薬フォ ーム。 8.各個体群のペレットが他の個体群とは、前記ペレットを包囲するコーチン グにおける前記ポリマー材料に対する前記疎水性剤の割合において異なっている 請求項1記載の単位投薬フォーム。 9.前記ポリマー材料が、アクリル酸エステルおよびメタクリル酸エステルの コポリマー、第4アンモニウム塩基を有するアクリル酸エステルおよびメタクリ ル酸エステルのコポリマーと第4アンモニウム塩基、セルロースエーテル誘導体 、およびアクリル樹脂から成る群の少なくとも一種類である請求項8記載の単位 投薬フォーム。 10.前記治療用薬剤がdiltiazemの薬学的に受容可能な形態であり、前記コ アは少なくとも一種類の加工助剤を含み、また前記ポリマー材料は、少なくとも 一種類の可塑剤との組合わせにおけるアクリル酸エステルおよびメタクリル酸エ ステルと6%未満の第4アンモニウム基とのコポリマーを含んで成り、前記疎水 性剤はステアリン酸塩である請求項8記載の単位投薬フォーム。 11.前記治療用薬剤がdiltiazemの薬学的に受容可能な形態であり、前記コ アは少なくとも一種類の加工助剤を含み、また前記ポリマー材料はアクリル酸エ ステルおよびメタクリル酸エステルのコポリマーを含んでおり、前記疎水性剤は ステアリン酸塩である請求項8記載の投薬フォーム。 12.少なくとも3種類の個体群のペレットが存在する請求項8記載の投薬フ ォーム。 13.少なくとも2種類の個体群のペレットが存在する請求項8記載の投薬フ ォーム。 14.ペレットのコア内の調節剤の量が他の全ての個体群のペレットにおける 調節剤の量とは異なっていて、放出時間の制御に寄与する請求項1記載の投薬フ ォーム。 15.前記カプセルがゼラチンカプセルである請求項1記載の投薬フォーム。 16.前記ポリマー材料が、使用環境において遭遇するpH範囲にわたってpHに は影響されない請求項1記載の投薬フォーム。 17.a)請求項1において定義したように複数個のコアを生成する工程と、 b)第一個体群の前記コアを請求項1において定義したコーチングをも って均一に塗布し、それによってフィルム塗布したペレットの個体群を生成する 工程であって、前記ペレットは水および前記治療用薬剤に対し限定された浸透性 を有し、それにより前記ペレットの使用環境に対する暴露の後、特定の時間にお いて水が前記コア内に拡散し、治療用薬剤が前記コアから前記使用環境内へ拡散 する工程と、 c)少なくとも一種類の別の個体群のコアを請求項1において定義した コーチングをもって均一に塗布し、それによってフィルム塗布したペレットの少 なくとも一種類の別の個体群を生成する工程であって、前記ペレットは水および 前記治療用薬剤に対し限定された浸透性を有し、それにより前記ペレットの前記 使用環境に対する暴露の後、他の個体群のペレットの特定の時間とは異なった特 定の時間において水が前記コア内に拡散し、治療用薬剤が前記コアから前記使用 環境内へ拡散し、各個体群のペレットは少なくとも1時間づつ他の個体群の平均 放出時間とは別の平均放出時間を有する工程と、 d)異なった個体群のペレットを所定割合で混合する工程と、 e)前記混合物の所定量の集合体を形成する工程と、 f)各集合体を、使用環境においてその一体性を維持しないキャリヤー ・メジウム内に共に保持して、単位投薬フォームを調製する工程であって、前記 キャリヤー・メジウムがカプセル、錠剤、座薬およびパウチから成る群から選択 されるものとを含むことを特徴とする水性液体含有環境内へ複数の逐次的、脈動 性放出状態において治療用薬剤を投与するための単位投薬フォームを調製する方 法。 18.a)使用の環境においてその一体性を維持しないキャリヤー・メジウム と、 b)前記キャリヤー・メジウムによって共に保持される少なくとも一種類 の個体群のペレットであって、前記個体群のペレットは、前記環境と接触した後 、治療用薬剤が所定の時間において前記環境内に放出されるように調整されてお り、 c)各ペレットは1)前記治療用薬剤および治療用薬剤とは異なる薬剤で ある調節剤を含むコアであって、前記調節剤は水に可溶であり、溶解したとき浸 透圧効果を提供するものと、2)前記コアを包囲する放出制御コーチングであっ て、少なくとも1種類の水浸透性、フィルム形成、水不溶性ポリマー材料と疎水 性剤とから成り、前記疎水性剤は脂肪酸、ワックスおよび脂肪酸の不溶性塩類か ら成る群から選択されるものであり、前記疎水性剤は前記水不溶性ポリマー材料 の少なくとも25%の量で存在し、前記個体群のペレットは略均一なコーチング を備えており、これが前記環境に暴露後、水を前記コアに侵入させ、かつこのコ ーチングを介して治療用薬剤を少なくとも1時間で前記環境内に拡散させること を特徴とする治療用薬剤を少なくとも一回の脈動性放出状態において、水性液体 含有環境内に投与するための単位投与フォーム。 19.前記放出制御コーチングを伴わない前記治療用薬剤の迅速放出供給体を 含むことによって2脈動性投薬フォームを提供し、前記使用環境に対する暴露後 、前記迅速放出供給体から第一の脈動が迅速に出現し、第二の脈動は前記放出制 御コーチングによって前記迅速放出供給体から少なくとも1時間遅延する請求項 18記載の単位投薬フォーム。 20.治療用薬剤の前記迅速放出体がペレット状である請求項19記載の単位 投薬フォーム。
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Application Number | Priority Date | Filing Date | Title |
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US07/878,416 US5260068A (en) | 1992-05-04 | 1992-05-04 | Multiparticulate pulsatile drug delivery system |
PCT/US1993/005922 WO1994028882A1 (en) | 1992-05-04 | 1993-06-03 | Multiparticulate pulsatile drug delivery system |
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JPH09500866A true JPH09500866A (ja) | 1997-01-28 |
JP3877329B2 JP3877329B2 (ja) | 2007-02-07 |
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JP51740894A Expired - Lifetime JP3877329B2 (ja) | 1992-05-04 | 1993-06-03 | 多粒状物の脈動性投薬システム |
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US (2) | US5260068A (ja) |
EP (1) | EP0701437B1 (ja) |
JP (1) | JP3877329B2 (ja) |
AT (1) | ATE215818T1 (ja) |
AU (1) | AU680620B2 (ja) |
CA (1) | CA2163433C (ja) |
DE (1) | DE69331806T2 (ja) |
ES (1) | ES2173891T3 (ja) |
WO (1) | WO1994028882A1 (ja) |
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US4917899A (en) * | 1983-12-22 | 1990-04-17 | Elan Corporation Plc | Controlled absorption diltiazem formulation |
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EP0230654B1 (en) * | 1985-12-28 | 1992-03-18 | Sumitomo Pharmaceuticals Company, Limited | Sustained pulsewise release pharmaceutical preparation |
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US5000962A (en) * | 1989-08-25 | 1991-03-19 | Schering Corporation | Long acting diltiazem formulation |
DK469989D0 (da) * | 1989-09-22 | 1989-09-22 | Bukh Meditec | Farmaceutisk praeparat |
US5017381A (en) * | 1990-05-02 | 1991-05-21 | Alza Corporation | Multi-unit pulsatile delivery system |
US5286497A (en) * | 1991-05-20 | 1994-02-15 | Carderm Capital L.P. | Diltiazem formulation |
-
1992
- 1992-05-04 US US07/878,416 patent/US5260068A/en not_active Expired - Lifetime
-
1993
- 1993-06-03 CA CA002163433A patent/CA2163433C/en not_active Expired - Lifetime
- 1993-06-03 EP EP93916656A patent/EP0701437B1/en not_active Expired - Lifetime
- 1993-06-03 JP JP51740894A patent/JP3877329B2/ja not_active Expired - Lifetime
- 1993-06-03 WO PCT/US1993/005922 patent/WO1994028882A1/en active IP Right Grant
- 1993-06-03 ES ES93916656T patent/ES2173891T3/es not_active Expired - Lifetime
- 1993-06-03 AT AT93916656T patent/ATE215818T1/de not_active IP Right Cessation
- 1993-06-03 US US08/244,745 patent/US5508040A/en not_active Expired - Lifetime
- 1993-06-03 DE DE69331806T patent/DE69331806T2/de not_active Expired - Fee Related
- 1993-06-03 AU AU46434/93A patent/AU680620B2/en not_active Ceased
Cited By (7)
Publication number | Priority date | Publication date | Assignee | Title |
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JP2002528485A (ja) * | 1998-11-02 | 2002-09-03 | チャーチ、 マリア ジェイ. | 多粒子改質放出組成物 |
JP2002537319A (ja) * | 1999-02-26 | 2002-11-05 | アンドルックス ファーマスーティカルズ インコーポレーテッド | 放出制御されたブプロピオン製剤 |
JP2007504141A (ja) * | 2003-08-29 | 2007-03-01 | アドバンシス ファーマスーティカル コーポレイション | 抗生物質製剤、その使用法及び作成方法 |
JP2012506861A (ja) * | 2008-10-23 | 2012-03-22 | ヘンケル コーポレイション | 加工デンプンを含む医薬ペレット、およびそれの治療への応用 |
JP2012508228A (ja) * | 2008-11-07 | 2012-04-05 | サムヤン コーポレイション | メチルフェニデートの放出制御用薬剤学的組成物 |
JP2015083599A (ja) * | 2008-11-07 | 2015-04-30 | サムヤン バイオファーマシューティカルズ コーポレイション | メチルフェニデートの放出制御用薬剤学的組成物 |
JP2015517998A (ja) * | 2012-04-13 | 2015-06-25 | ハンミ ファーム. シーオー., エルティーディー. | 硬カプセル中にカプセル化された複数単位球状錠剤(must)を含む複合製剤およびこれらの製造方法 |
Also Published As
Publication number | Publication date |
---|---|
ES2173891T3 (es) | 2002-11-01 |
WO1994028882A1 (en) | 1994-12-22 |
US5260068A (en) | 1993-11-09 |
DE69331806D1 (de) | 2002-05-16 |
AU4643493A (en) | 1995-01-03 |
US5508040A (en) | 1996-04-16 |
EP0701437A4 (en) | 1996-10-09 |
AU680620B2 (en) | 1997-08-07 |
EP0701437A1 (en) | 1996-03-20 |
CA2163433C (en) | 2003-07-08 |
JP3877329B2 (ja) | 2007-02-07 |
ATE215818T1 (de) | 2002-04-15 |
CA2163433A1 (en) | 1994-12-22 |
DE69331806T2 (de) | 2003-01-16 |
EP0701437B1 (en) | 2002-04-10 |
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